Clinical nutrition products need to be notified nationally


New Delegated Regulation (EU) 2016/128 concerning composition of Foods for special medical purposes (FSMP) and information provided on them is applied from 22 February 2019 onwards. The new regulation requires that label and other relevant information to verify the compliance with the new regulation will be submitted to the national competent authorities. Following this, Finland, along with other EU countries,  will require a notification procedure for FSMP products once they, for the first time, enter the national market. Concerning FSMP products for infants, regulation will be applied one year later, 22 February 2020 onwards.

FSMP products are intended for subjects with a disease or medical condition requiring such dietary management that nutritional needs cannot be easily met with ordinary food items. Foods for special medical purposes are used under the supervision and control of health care professionals.

According to new Delegated regulation, presentation of nutrition and health claims are not allowed on the labelling or marketing material of the products. For which condition the product is intended as dietary management is allowed to be expressed and  essentially should also be presented accompanied by  other mandatory labelling.

Medfiles’ Food&Nutrition team will assist you to have your products in compliance with the new regulation!

For further information visit our website or contact

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